FDA Awards Breakthrough Device Status to ORTHOSON's Bio-Structural Gel

Wednesday, February 07, 2024

ORTHOSON, an innovative medical technology company focused on developing advanced treatments for back pain, announced today that its Bio-Structural Gel has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This revolutionary gel targets back pain caused by degenerative disc disease by navigating natural fissures within intervertebral discs before solidifying to form a supportive biological structure. Developed in collaboration with leading institutions such as the University of Oxford's Institute of Biomedical Engineering, the University of Sheffield, and Sheffield Hallam University, the Bio-Structural Gel is set to enter clinical trials next year.

The FDA's Breakthrough Devices Program expedites the evaluation and review process for innovative medical devices aimed at treating life-threatening or debilitating conditions. ORTHOSON's expertise in regulatory affairs and strategic partnerships have facilitated the achievement of this prestigious designation.

Under the Breakthrough Device Program, ORTHOSON will receive support in areas such as streamlined clinical study design, priority review by FDA teams, engagement with senior FDA officials, expedited assessment of manufacturing compliance, and consideration of premarket and postmarket data. These measures will enable ORTHOSON to demonstrate the safety and efficacy of its Bio-Structural Gel, with the ultimate goal of providing relief to patients suffering from degenerative disc disease.


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